Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The Quality Assurance Specialist will provide support for supplier qualification (CDMO/CLOs), and process improvement activities. This role will also support Denali Quality Systems.
Key Accountabilities/ Core Job Responsibilities:
Support supplier qualification and conduct quality audits for Denali sites including CDMOs/CTLs
Supports tracking/reporting departmental metrics for Quality Systems Management Reviews
Supports Quality Systems and Operations, including document control, change controls, deviations, CAPAs, effectiveness checks and temperature excursions.
Writes changes to controlled documents (SOPs, Work Instructions, Specifications, etc.) as needed
Responsible for ensuring compliance to cGMPs per regulations
Makes improvement in Quality processes and systems
Supports efforts to implement and utilize the internal electronic document management system.
Supports Quality review of IND/IMPD/BLA/NDA
Supports and participates in regulatory body inspection readiness
May interface with regulatory agencies as required.
Qualifications/Skills:
BS in a scientific discipline with 5+ years of cGMP experience in Pharmaceutical Quality Assurance
Current and strong working knowledge of 21 CFR Parts 210-211 and 11; EU cGMP/GLPs; and ICH Quality and development guidelines.
Experience with electronic Quality Management Systems.
Driven, results-oriented self-starter and excellent team player.
Excellent verbal and written communication skills.
Creative and pragmatic approach to problem solving and issue resolution.
Maintain a strong attention to detail.
Ability to closely follow Quality Standards and company Quality expectations
Committed to Denali values of growth, unity, grit, and trust; as well as values related to accountability, transparency, and scientific rigor
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Skills Required
- Bachelor of Science degree in a scientific discipline
- 5+ years of cGMP experience in pharmaceutical quality assurance
- Strong working knowledge of 21 CFR Parts 210-211 and Part 11
- Knowledge of EU cGMP and GLP requirements
- Knowledge of ICH Quality and development guidelines
- Experience with electronic Quality Management Systems
- Excellent verbal and written communication skills
- Strong attention to detail
- Ability to follow quality standards and company quality expectations
Denali Therapeutics Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Denali Therapeutics and has not been reviewed or approved by Denali Therapeutics.
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Healthcare Strength — Health coverage is described as strong, with the employee premium covered in certain cases. Core medical benefits are consistently highlighted in public materials and postings.
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Retirement Support — A 401(k) plan with employer safe-harbor contributions is confirmed by company materials. Contributions are described as being deposited each payroll, signaling dependable support for retirement savings.
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Equity Value & Accessibility — An employee stock purchase plan is offered and enhanced by a “Cashless Participation” feature through a vendor partnership, improving ease of participation. Equity programs are also referenced in job postings and filings.
Denali Therapeutics Insights
What We Do
Denali Therapeutics is dedicated to defeating neurodegenerative diseases by breaking through historical barriers in scientific research and clinical development in order to deliver safe and effective medicines to patients and families. Our scientific approach is based on three core principles: rigorous assessment of genetic targets, engineering brain delivery, and using biomarkers to guide development. Our team thrives in a work environment that is scientifically driven, impact-focused, supportive, and collaborative. Our ability to have a positive impact on people’s lives is directly related to the trust we have in each other and our ability to unify our diverse backgrounds and experience behind our purpose to defeat degeneration.
